A Phase 1 Evaluation of the Safety and Immunogenicity of the Recombinant Live Attenuated Tetravalent Dengue Virus Vaccine Admixtures TV003 and TV005 in Healthy Flavivirus-experienced Adult Subjects

NCT01506570 Phase 1 COMPLETED

Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. This study will evaluate the safety and immune responses to two formulations of a tetravalent dengue virus vaccine in healthy adults who have previously been infected with a dengue virus or other flavivirus or have previously received a flavivirus vaccine.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	COMPLETED
Enrolment	58
Start date	2011-12
Completion	2013-09

Conditions

• Dengue

Interventions

• TetraVax-DV Vaccine - Admixture TV003
• TetraVax-DV Vaccine - Admixture TV005
• Placebo

Primary outcomes

• Safety of TetraVax-DV TV003 and TV005, as assessed by the frequency of vaccine-related adverse events — Measured through Day 360
• Immunogenicity of TV003 and TV005, as assessed by neutralizing antibody titers to DENV-1, DENV-2, DENV-3, and DENV-4 — Measured 28, 56, 90, and 180 days after each vaccination
  Monovalent, bivalent, trivalent, and tetravalent seropositivity rates will be determined at 28, 56, and 90 days after each vaccination.
• Whether a second dose of the vaccine given at Day 180 will induce seropositivity in those participants that remained seronegative to one or more DENV serotypes following the first vaccination — Measured through Day 360

Countries

United States